Surgical hand access apparatus

ABSTRACT

A hand access device includes a housing defining a longitudinal axis and having a passageway therethrough dimensioned to permit passage of a surgeon&#39;s arm and a fabric seal mounted within the opening and being dimensioned to form a substantial sealing relation with the surgeon&#39;s arm. The fabric seal is elongated extending along the longitudinal axis and may define a general hour glass configuration. A pair of flexible bands may be mounted about the fabric seal. The flexible bands are adapted to engage an outer surface of the seal to bias the fabric seal to a closed position thereof.

CROSS REFERENCE TO RELATED APPLICATIONS

The present application claims the benefit of priority of U.S.Provisional Application Ser. No. 60/465,932, filed on Apr. 25, 2003, theentire contents of which are hereby incorporated by reference.

BACKGROUND

The present disclosure relates to surgical devices and more particularlyto a surgical access device for use in a minimally invasive surgicalprocedure.

Minimally invasive surgical procedures including both endoscopic andlaparoscopic procedures permit surgery to be performed on organs,tissues and vessels far removed from an opening within the tissue.Laparoscopic and endoscopic procedures generally require that anyinstrumentation inserted into the body be sealed, i.e. provisions mustbe made to ensure that gases do not enter or exit the body through theincision as, for example, in surgical procedures in which the surgicalregion is insufflated. These procedures typically employ surgicalinstruments which are introduced into the body through a cannula. Thecannula has a seal assembly associated therewith. The seal assemblyprovides a substantially fluid tight seal about the instrument topreserve the integrity of the established pneumoperitoneum.

Minimally invasive procedures have several advantages over traditionalopen surgery, including less patient trauma, reduced recovery time,reduced potential for infection, etc . . . However, despite its recentsuccess and overall acceptance as a preferred surgical technique,minimally invasive surgery, such as laparoscopy, has severaldisadvantages. In particular, surgery of this type requires a great dealof surgeon skill in order for the surgeon to manipulate the long narrowendoscopic instruments about a remote site under endoscopicvisualization. In addition, in laparoscopic surgery involving theintestinal tract it is often preferable to manipulate large sections ofthe intestines to perform the desired procedure. These manipulations arenot practical with current laparoscopic tools and procedures accessingthe abdominal cavity through a trocar or cannula.

SUMMARY

Accordingly the present disclosure is directed to an access device foruse during a surgical procedure. The access device includes a housingdefining a longitudinal axis and having a passageway therethroughdimensioned to permit passage of a surgeon's arm, and a fabric sealmounted within the opening. The fabric seal is dimensioned to form asubstantial sealing relation with the surgeon's arm. The fabric seal iselongated extending along the longitudinal axis. The hand access devicedefines a constriction. For example, the fabric seal may define anhourglass configuration. The device may further include a pair offlexible bands which are mounted about the fabric seal to form aconstriction. The flexible bands are adapted to engage an outer surfaceof the seal to bias the fabric seal to a constricted or closed positionthereof. The flexible bands are connected to each other at respectiveend portions thereof and are arranged in opposed relation. The flexiblebands are adapted to bow outwardly upon passage of the surgeon's armthrough the fabric seal, and return to the constricted or closedposition in the absence of the surgeon's arm. The fabric seal mayinclude a lubricious coating.

In an alternate embodiment, an assembly for permitting access to a bodycavity, includes a base retractor which is at least partiallypositionable within an opening in tissue and adapted to at leastpartially retract the tissue surrounding the opening. The base retractordefines a longitudinal axis and has a longitudinal channel extendingalong the longitudinal axis. The assembly further includes a hand accessdevice mounted to the base retractor. The hand access device includes ahousing member having a passageway dimensioned to permit passage of asurgeon's arm or hand and a fabric seal disposed within the housingmember. The fabric seal defines a seal opening adapted to form asubstantial sealing relation with the surgeon's arm or hand. The fabricseal is normally biased to a position wherein the seal opening issubstantially closed.

At least one flexible band is mounted adjacent a periphery of the fabricseal. The flexible band is normally biased to engage the fabric seal andcause the fabric seal to assume a position where the seal opening issubstantially closed. A pair of flexible bands may be mounted about theperiphery of the fabric seal. The flexible bands are normally biased toengage the fabric seal to substantially close the seal opening thereof.The flexible bands are further adapted to move in a radial outwarddirection upon passage of the surgeon's arm or hand through the fabricseal. The flexible bands are connected at respective end portionsthereof and are adapted to bow outwardly upon passage of the surgeon'sarm or hand. The flexible bands may include slots therein to enhanceflexibility.

The hand access device may be releasably mounted to the base retractorand preferably mounted for rotational movement relative to the baseretractor.

BRIEF DESCRIPTION OF THE DRAWING(S)

Preferred embodiments of the present disclosure will be betterappreciated by reference to the drawings wherein:

FIG. 1 is a perspective view of the hand access apparatus in accordancewith an embodiment of the present disclosure;

FIG. 2 is a perspective view with parts separated of the apparatus ofFIG. 1;

FIG. 3 is a cross-sectional view of the apparatus of FIG. 1;

FIG. 4 is a top plan view of the apparatus of FIG. 1;

FIG. 5 is an alternate embodiment in accordance with the presentdisclosure;

FIG. 6 is another alternate embodiment in accordance with the presentdisclosure; and

FIG. 7 is a view of a further embodiment in accordance with the presentdisclosure, including a retractor base.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT(S)

The hand access apparatus of the present disclosure provides asubstantial seal between a body cavity of a patient and the outsideatmosphere before, during and after insertion of an object e.g., a hand,through the apparatus. Moreover, the hand access apparatus of thepresent disclosure maintains a fluid tight interface about the arm topreserve the atmospheric integrity of a surgical procedure from gasand/or fluid leakage. Specifically, the hand access apparatusaccommodates angular manipulation of the arm relative to a seal axis.This feature of the present disclosure desirably minimizes the entry andexit of gases and/or fluids to/from the body cavity.

The hand access apparatus may be used in conjunction with a base unit,e.g., a retractor base, which is positionable within an incisionaccessing, e.g., the abdominal cavity.

In the following description, as is traditional the term “proximal”refers to the portion of the instrument closest to the operator whilethe term “distal” refers to the portion of the instrument remote fromthe operator.

Referring now to the drawings, in which like reference numerals identifyidentical or substantially similar parts throughout the several views,FIGS. 1–4 illustrate an embodiment of a hand access apparatus of thepresent disclosure. Hand access apparatus 100 includes housing 102defining a housing axis “a” extending the length of the axis “a” andseal 104 mounted within the housing 102. Housing 102 desirablyincorporates several components assembled together to define a singleunit, namely, main body 106 and end caps 108 connected at each end ofthe main body 106. The components of housing 102 may be fabricated fromany conventional biocompatible rigid material including moldablepolymeric materials, stainless steel or the like. End caps 108 areconnected to the main body 106 through a compression fit and/or spotwelding. Other means for securing these components are also envisioned.End caps 108 serve to secure seal 104 within housing 102 as will bediscussed.

Seal 104 is preferably a fabric seal and is desirably arranged so as tohave a constriction. For example, the seal may have the general shape ofan hourglass. Each end 110 of seal 104 is secured to housing 102 bypositioning the respective seal end 110 within a slot defined betweeneach end cap 108 and main body 106 and thereafter securing the end cap108 to the main body 106 via the aforedescribed compression fit. Othermeans for securing the seal ends 110 to housing 102 are also envisionedincluding adhesive means, spot welding, etc.

Seal 104 preferably includes a fabric material, such as woven material,a braided material, or a knitted material. The type of material isselected to provide a desired expansiveness. For example, a braid ofvarying end count and angle may be selected. Any natural or man-madematerial may be used for the fabric. In certain embodiments, a syntheticmaterial such as nylon, Kevlar (Trademark of E.I. DuPont de Nemours andCompany) or any other material that will expand and compress about anarm inserted through housing 102 is used. The selected materialdesirably minimizes or prevents the formation of gaps when the hand isintroduced into housing 102. The material of seal 104 may be porous orimpermeable to the insufflation gas. If porous, seal 104 may include acoating of an elastomeric material which is impermeable to theinsufflation gas or at least a portion of the seal 104 may be coated. Inaddition, the fabric may be coated on its interior with urethane,silicon or other flexible lubricious materials to facilitate passage ofthe hand and arm through the fabric seal 104. In certain embodiments,the fabric is gathered about the axis “a” so as to form a constrictionor closed portion. The fabric is desirably constructed of a materialand/or arranged so that the fabric forms a constriction or closure. Theseal may also be molded so as to have a constriction or may be knitted,braided or woven so as to have a constriction. For example, the seal 104is desirably formed as disclosed in U.S. Provisional Patent ApplicationNos. 60/540,421, filed Jan. 30, 2004 and 60/466,005, filed Apr. 25,2003, the disclosures of which are hereby incorporated by referenceherein. For example, the fabric is desirably comprised of a plurality ofstrands woven, braided, or knitted together the strands may includemultifilament and/or monofilament strands of polypropylene, nylon,teflon, polyethylene terepthalate (“PET”) and/or polyarylether-etherketone (“PEEK”). The fabric is desirably molded, extruded, sprayed,dipped, corrugated or otherwise formed with an elastomeric material suchas thermoplastic elastomers (“TPE”), polyurethane, polyisoprene,silicone, monprene, stanoprene.

With continued reference to FIGS. 1–4, in a preferred embodiment, seal104 further includes a resilient member, such as a pair of flexiblebands 112 which are positioned adjacent the midsection or neck of theseal 104. Flexible bands 112 are made of a suitable flexible materialsuch as stainless steel, spring steel, shape memory metals, etc . . .Flexible bands 112 are secured to the outer periphery of seal 104 withadhesives or the like or alternatively could be sewn onto or into thefabric. Flexible bands 112 are preferably pivotally connected at theirrespective ends with pivot pins 114. Flexible bands 112 are adapted topivot about pivot pins 114 and bow outwardly from a closed positiondepicted in FIG. 4 to the open position depicted in FIG. 3 to permitpassage of the hand and arm through housing 102. In alternativeembodiments, the resilient member comprises a single member or more thantwo members operatively connected.

Flexible bands 112 are normally biased to the closed position and assumethis position in the absence of the surgeon's hand to completely closethe seal opening. Flexible bands 112 may be coated with either urethane,silicon or other flexible lubricious coating materials. Flexible bands112 preferably possess an open u-shape in cross-section as depicted inFIGS. 1 and 3 to approximate the entry and exit funnel shape of the hourglass seal to thereby facilitate entry and exit movement of thesurgeon's hand. In one embodiment, flexible bands 112 are moved to theopen position of FIG. 3 by direct engagement with the surgeon's hand orarm passing through housing 102. It is also envisioned that a separatemechanism could be provided to manually open and close flexible bands112 independent of the engagement with the hand of the surgeon. Othermeans of biasing the seal 104 closed may be used, such as foam supports,gel packing, pressurized fluid chambers, for example. In otherembodiments, the biasing means is omitted. In further embodiments, thebiasing means is omitted and an additional seal, such as a flapper valveor duck bill valve, is used in addition to seal 104.

FIG. 5 illustrates an alternate embodiment of the hand access apparatusof the present disclosure. This embodiment is substantially similar tothe embodiment of FIGS. 1–4. However, with this embodiment, flexiblebands 112 are greater in length to extend beyond the outer periphery ofhousing 102. With this arrangement, flexible bands 112 open to a largerdimensioned opening in the open configuration of the seal 104.

FIG. 6 illustrates another alternate embodiment where the flexible bands112 have a u-shaped cross-section and the legs of the u-shape includecuts or slots 116 to facilitate the bowing action.

With reference now to FIG. 7, there is illustrated a further embodimenthaving a hand access apparatus in combination with a base retractor unit200 which is positioned within an opening in the abdominal wall. Baseretractor unit 200 includes lower member 202, flexible sleeve 204extending from the lower member 202 and upper member 206. Lower member202 is positionable within the abdominal cavity. Preferably, lowermember 202 is an elastomeric or resilient ring, such as a metallic ring,or polymeric ring which is suitably flexible to be deformed into anoblong shape to permit entry within the incision, but which returns toits normal annular shape upon release within the abdominal cavity.Suitable materials for lower member 202 include spring steel, shapememory metals, elastomeric materials, etc . . . It is also envisionedthat lower member 202 may be an annular inflatable member which isselectively inflatable to a desired configuration.

Flexible sleeve 204 is preferably fabricated from an impermeable medicalgrade material, e.g., including an elastomeric or latex material. Thesleeve 204 is preferably tubular in shape and integral with or connectedto lower member 202 through conventional means. Flexible sleeve 204 maybe dimensioned to retract the tissue upon its deployment within openingand also serve as a barrier preventing fluids from entering theincision. Upper member 206 may be an elastomeric or resilient ring fortensioning the sleeve 204 and retracting the incision in the abdominalwall, such as a polymeric or metallic ring, or alternatively, aninflatable member similar in design to lower member 202.

Hand access apparatus 100 may be releasably mounted to base retractorunit 200 through conventional means including a snap or interferencefit, or e.g., a bayonet coupling. Desirably, the upper member 206includes a relatively rigid member to facilitate the mounting of theapparatus. In one preferred arrangement, base retractor unit 200includes a quick connect detent or ball bearing mechanism, identifiedgenerally as reference numeral 208, to connect the two components. Withthis arrangement, the ball bearings are arranged to engage correspondingannular recesses in the exterior of housing 102. In this regard, handaccess apparatus 100 may swivel or rotate about axis “a” relative to thebase retractor unit. Other means for connecting the two components areenvisioned as well, such as latches, bayonet connections, etc. An o-ringseal may be provided to prevent loss of fluid through the components. Itis also envisioned that a second zero-closure valve 210 may be mountedto the proximal end of hand access apparatus 100 or to base retractorunit 200. This valve 210 may be a duckbill, flapper, single slit ordouble slit zero-closure valve, an iris valve or seal comprised of gelmaterials. The second valve 210 may remove the need for the fabric seal104 to completely close in its unexpanded state. In further embodiments,the upper member 206 of the base retractor unit comprises at least onetab for engaging and fixing the sleeve 204 after tensioning.

In use in a laparoscopic procedure, an incision is made in the abdominalwall of the insufflated abdominal cavity. Base retractor unit 200 ispositioned within the incision by deforming lower member 202 to a narrowconfiguration to pass through the opening and thereafter releasing themember within the abdominal cavity. Flexible sleeve 204 thus lines theincision with the outer member disposed exterior of the body.Preferably, the sleeve is tensioned so as to retract the incision.Thereafter hand access apparatus 100 is mounted to base retractor unit200 in the aforedescribed manner. The surgeon thereafter passes his handand arm through seal 104 whereby the flexible bands 112 bow outwardly.Seal 104 engages the arm in substantially fluid tight manner to preventrelease of insufflation gases. Surgery is then performed with the sealpermitting off-axis manipulation of the arm while maintaining thedesired seal about the arm. Upon completion, the surgeon's arm iswithdrawn and the seal 104 returns to its normal constricted positionclosing seal 104 and preventing gasses from escaping through theapparatus.

While the invention has been particularly shown, and described withreference to the preferred embodiments, it will be understood by thoseskilled in the art that various modifications and changes in form anddetail may be made therein without departing from the scope and spiritof the invention. For example, the resilient member disposed around thefabric seal may comprise an elastomeric band, or other resilient member.Accordingly, modifications such as those suggested above, but notlimited thereto, are to be considered within the scope of the invention.

1. A hand access device, which comprises: a housing defining alongitudinal axis and having a passageway therethrough dimensioned topermit passage of a surgeon's arm; and a fabric seal mounted within thepassageway, the fabric seal including a fabric material and anelastomeric material different from the fabric material, and havinginner seal portions adapted to permit passage of the surgeon's armthrough the fabric seal and in substantial sealing relation therewith,the fabric seal being elongated extending along the longitudinal axis todefine entry and exit seal ends, and an intermediate seal portionbetween the entry and exit ends; and at least one flexible band mountedabout the fabric seal and in contacting engagement with at least theintermediate seal portion of the fabric seal and adapted to bias theinner seal portions of the fabric seal toward a closed position thereof.2. The hand access device of claim 1 wherein the fabric seal is twistedabout the longitudinal axis so as to form a constriction.
 3. The handaccess device of claim 1 wherein the fabric seal is arranged to define aconstriction.
 4. The hand access device according to claim 1, whereinthe fabric seal generally defines an hourglass configuration.
 5. Thehand access device according to claim 1 including pair of flexible bandsconnected to each other at respective end portions thereof, the flexiblebands arranged in opposed relation in contacting relation with theintermediate portion of the fabric seal whereby the flexible bands areadapted to bow outwardly upon passage of the surgeon's arm through thefabric seal, and return in the absence of the surgeon's arm to bias theinner seal portions of the flexible seal toward the closed position. 6.The hand access device according to claim 5 wherein the flexible bandsinclude slots therein to facilitate bowing outwardly of the flexiblebands during passage of the surgeon's arms.
 7. The hand access deviceaccording to claim 5 wherein the flexible bands are connected to eachother at respective end portions about respective pivot pins.
 8. Thehand access device according to claim 1 wherein the fabric sealcomprises a lubricious coating.
 9. The hand access device according toclaim 1 wherein the elastomeric material is impregnated within thefabric material of the fabric seal.
 10. The hand access device accordingto claim 1 wherein the fabric material is coated with the elastomericmaterial of the fabric seal.
 11. The hand access device according toclaim 1 including a base retractor mounted to the housing, the baseretractor at least partially positionable within an opening in tissueand adapted to at least partially retract the tissue surrounding theopening, the base retractor defining a longitudinal axis and having alongitudinal channel extending along the longitudinal axis.
 12. The handaccess device according to claim 11 wherein the housing is mounted forrotational movement relative to the base retractor.
 13. The hand accessdevice according to claim 1 wherein the fabric material is selected fromthe group consisting of a woven fabric, a knitted fabric, a braidedfabric and a felted fabric.
 14. The hand access apparatus according toclaim 1 wherein, the inner seal portions of the fabric seal are movablefrom a first substantially closed position to a second displacedposition to thereby define an internal opening to permit passage of thesurgeon's arm.
 15. A hand access device, which comprises: a housingdefining a longitudinal axis and having a passageway therethroughdimensioned to permit passage of a surgeon's arm; an elongated sealmounted within the passageway, the elongated seal extending along thelongitudinal axis to define entry and exit seal ends, and anintermediate seal portion between the entry and exit seal ends, at leastthe intermediate seal portion adapted to establish a general sealedrelation with an object introduced through the elongated seal; and apair of opposed flexible bands mounted about the elongated seal andengageable with the intermediate seal portion, the flexible bandsadapted to bias the intermediate seal portion to substantially close apassage of the elongated seal.
 16. The hand access device according toclaim 15 wherein the elongated seal comprises a fabric material and anelastomeric material different from the fabric material.